ISO 9003 Translated into Plain English

ISO 9003 is for Organizations that Assure Quality
through Final Inspection and Testing

ISO 9003 is a Quality Assurance Model
made up of Quality System Requirements

ISOQAR

This section summarizes ISO 9003. It highlights the main points.
It does not present detail. If you need a detailed and complete interpretation
of the ISO 9003 standard, please consider purchasing our hardcopy version.

ISO 9003 is a quality assurance model made up of quality system requirements. This model applies to organizations that assure quality through final inspection and testing. ISO expects organizations to apply this model, and to meet these requirements, by developing a quality system.

ISO 9003 is made up of 16 sets of quality system requirements. However, it is numbered from 4.1 to 4.20. This is because ISO 9003 retains 9001's 20 part numbering system. As you read the following material, you will notice that items 4.4, 4.6, 4.9, and 4.19 are not required by ISO 9003.

ISO 9003 4.1 - Management responsibilities

• Define a quality policy. Your policy should describe your organization's attitude towards quality.

• Define the organizational structure that you will need in order to manage your quality system.

  • Define quality system responsibilities, give quality system personnel the authority to carry out these responsibilities, and ensure that the interactions between these personnel are clearly specified. Also, make sure that all of this is well documented.

  • Identify and provide the resources that people will need to manage, perform, and verify quality system work.

  • Appoint a senior executive to manage your quality system and give him or her the necessary authority.

• Define a procedure that your senior managers can use to review the effectiveness of your quality system.

ISO 9003 4.2 - Quality system requirements

• Develop a quality system and a manual that describes it.

• Develop and implement quality system procedures that are consistent with your quality policy.

• Develop quality plans which show how you intend to fulfill quality system requirements. You are expected to develop quality plans for products, processes, projects, and customer contracts.

ISO 9003 4.3 - Contract review requirements

• Develop and document procedures to coordinate the review of sales orders and customer contracts. Make sure you include the customer in the process of review.

• Your contract review procedures should ensure that all contractual requirements are acceptable before you agree to provide products or services to your customers.

• Develop procedures which specify how customer contracts are amended, and which ensure that changes in contracts are communicated throughout the organization.

• Develop a record keeping system that you can use to document the review of customer orders and contracts.

ISO 9003 4.4 - Product design (not used by ISO 9003)

ISO 9003 4.5 - Document and data control

• Develop procedures to control quality system documents and data.

• Develop procedures to review, approve, and manage all of your quality system documents and data.

• Develop procedures to control changes to documents and data.

ISO 9003 4.6 - Purchasing (not used by ISO 9003)

ISO 9003 4.7 - Customer-supplied products

• Develop procedures to control products supplied to you by customers. These procedures should ensure that you:

  • Examine the product when you receive it to confirm that the right items were shipped without loss or damage.

  • Prevent product loss, misuse, damage, or deterioration through proper storage and security.

  • Record, and report to the customer, any product loss, misuse, damage, or deterioration.

  • Clarify who is responsible for the maintenance and control of the product while it is in your possession.

ISO 9003 4.8 - Product identification and tracing

• Develop and document procedures to identify and track your products. Track your products or product batches by means of unique identifiers and suitable record keeping.

ISO 9003 4.9 - Process control (not used by ISO 9003)

ISO 9003 4.10 - Product inspection and testing

• Develop procedures to inspect, test, and verify that final products meet all specified requirements before they are sold to customers.

• Ensure that product inspection and testing records are developed, and that your procedures ensure that these records are properly maintained.

ISO 9003 4.11 - Control of inspection equipment

• Develop procedures to control, calibrate, and maintain inspection, measuring, and test equipment used to demonstrate that your products conform to specified requirements (the term equipment includes both hardware and software).

• Develop procedures to ensure that your measurement equipment is appropriate, effective, and secure.

• Develop procedures to calibrate all of your quality oriented inspection, measuring, and test equipment.

ISO 9003 4.12 - Inspection and test status of products

• Control the inspection status of your products. Ensure that:

  • Each and every product is identified as having passed or failed the required tests and inspections.

  • The test status of each product is documented and respected throughout the production, installation, and servicing process.

  • Only products that have passed all tests and inspections are subsequently used or sold to customers (unless an official exception is made under section 4.13 below).

ISO 9003 4.13 - Control of nonconforming products

• Control nonconforming products to avoid inappropriate use or delivery.

• Make sure that all relevant persons are notified when your products do not conform to specified requirements.

• Record the actual condition of any nonconforming product that is, nevertheless, accepted and used. And record the repairs.

• Re-test and re-inspect products that have been repaired or reworked.

ISO 9003 4.14 - Corrective action

• Take corrective actions to handle product nonconformities.

ISO 9003 4.15 - Handling, storage, and delivery

• Develop and document procedures to handle, store, package, preserve, and deliver finished products after final inspection and testing.

• Develop product handling methods and procedures that prevent product damage or deterioration.

• Designate secure areas to store and protect your products.

• Develop procedures which specify how your products will be placed into storage and removed from storage.

• Develop procedures which specify how your products will be protected from damage or deterioration during storage.

• Develop procedures which specify how your products will be monitored and evaluated to detect damage or deterioration while in storage.

• Develop packing, packaging, and marking methods and procedures to protect and control the quality of products and packaging materials.

• Develop methods and procedures to protect and preserve product quality prior to delivery and while the product is still under your control.

• Develop procedures to protect your products after final testing and inspection, and during product delivery.

ISO 9003 4.16 - Control of quality records

• Develop a quality record keeping system and control its use. Your quality record keeping system should:

  • Show that your quality system is implemented.

  • Prove that your quality system works properly.

  • Prove that finished products meet requirements.

  • Specify how long old records should be retained.

  • Produce documents that are dated and easy to read.

ISO 9003 4.17 - Internal quality audit requirements

• Carry out internal quality audits in order to:

  • Determine whether quality activities and results comply with written quality plans, procedures, and programs.

  • Evaluate the performance of your quality system.

  • Verify the effectiveness of your corrective actions.

• Make sure that:

  • Auditors are independent of the people being audited.

  • Audit results, corrective actions, and corrective action results and consequences are properly recorded.

  • Deficiencies discovered during the audit are promptly corrected.

  • Audit conclusions are discussed with the people whose activities and results are being audited, and deficiencies are corrected.

  • Audit reports are fed back into the quality system review process.

ISO 9003 4.18 - Training requirements

• Make sure that the people who perform final inspection and testing activities are competent, and make sure that a record of their competence is maintained.

ISO 9003 4.19 - Servicing (not used by ISO 9003)

ISO 9003 4.20 - Statistical techniques

• Select the statistical techniques that you will need in order to control and verify your product characteristics.

• Use your statistical techniques and control how they are used.

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